- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06000176
Comparison of Optical Coherence Tomography Angiography Microvascular Changes in Primary Open Angle and Primary Angle Closure Glaucoma
Study Overview
Status
Intervention / Treatment
Detailed Description
After approval of the local institutional ethics committee and local institutional review board, all patients presenting to the outpatient clinic of the department of Ophthalmology in the universities has been subjected to routine ophthalmological examination including: best corrected visual acuity (BCVA), Slit-lamp evaluation of anterior segment, IOP by Goldmann applanation tonometer, Gonioscopy using gonio contact lens, Fundus examination by indirect opthalmoscope with history taking focusing on positive family history of glaucoma after a detailed informed consent was signed by eligible patients and investigated by OCTA of the Peripapillary and Macular vascular density on presentation using AngiVue (Optovue, Inc., Fremont, CA, USA).
Data analysis performed using the Statistical Package of Social Science (SPSS) software version 22 in windows 7 (SPSS Inc., Chicago, IL, USA) Simple descriptive statistical analysis in the form of numbers and percentages of qualitative data, and arithmetic means as central tendency measurement, standard deviations as a measure of dispersion of quantitative parametric data.
For quantitative parametric data: Independent samples test was used to compare quantitative measures between two independent groups, One-way analysis of variance ANOVA test used to compare quantitative measures between more than two independent groups of quantitative data with the benferroni Post-HOC to test the significance between each two groups, Paired t-test used to compare two dependent quantitative data.
For qualitative data Chi square test used to compare between two or more than two qualitative groups.
Bivariate Pearson correlation test to test the association between variables The probability value (P-value) < 0.05 was considered as statistical significant
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Fayoum, Egypt
- Athar Mohamed Mohamed Makhlouf
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years old.
- Fulfilling Diagnostic criteria of PACG patients :occluded angle by gonioscopy in which > 180˚ of trabecular meshwork cannot be seen , IOP>21, Optic disc and RNFL damage due to glaucoma
- Diagnosed POAG patient: open anterior chamber angle ,IOP>21 ,Optic disc and RNFL damage due to glaucoma
- Healthy patient: normal anterior chamber, open angle and normal fundus.
Exclusion Criteria:
- History of other causes of optic neuropathy.
- History of systemic diseases. (HTN, DM, Cardiac).
- Previous ocular surgeries or Laser iridotomy.
- Poor quality of OCTA image less than 4/10.
- Refractive errors > 6 diopters sphere, >3 diopter cylinder
- Poor cooperation or fixation with the OCTA examination.
- Secondary causes of glaucoma
- Media opacity that interfere with quality of image (dense cataract,corneal opacity,…)
- Previous acute attack of ACG
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
interventional details : diagnostic test OCTA macula and ONH
interventional details : diagnostic test OCTA macula and ONH in the 3 groups
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diagnostic test OCTA macula and ONH
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OCTA macula and ONH
Time Frame: We will recruit patient that include the inclusion criteria from april2022 to july 2023
|
macular 6*6,3*3 and peripapillary vessel density
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We will recruit patient that include the inclusion criteria from april2022 to july 2023
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M557
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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